NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT SPECIAL EMPHASIS AREAS FOR USE IN DISCRETIONARY FUNDING Release Date: May 14, 1998 P.T. National Institute of Child Health and Human Development PURPOSE The purpose of this notice is to highlight the special emphasis areas that the National Institute of Child Health and Human Development (NICHD) will consider in Fiscal Years 1999 and 2000 when making discretionary funding decisions. This notice is a revision of the previous notice concerning the NICHD's discretionary funding, or select-pay, process published in the NIH Guide for Grants and Contracts, Vol. 24, No. 31, August 25, 1995. BACKGROUND The NICHD has primary responsibility for supporting basic, clinical and applied research and research training in maternal and child health and human development; reproductive biology and fertility regulation; population dynamics; developmental biology and teratology; clinical nutrition; perinatal and infant morbidity and mortality; human learning and behavior; mental retardation and developmental disabilities; pediatric, adolescent and maternal AIDS; and medical rehabilitation. While the NICHD will continue to fund those projects that are deemed to be scientifically excellent and innovative within the full scope of its mission, this notice highlights scientific areas to be considered by the NICHD when making discretionary funding decisions. Formally establishing and publishing these special emphasis areas (SEAs) to be considered for discretionary funding will allow the NICHD to encourage submission of applications on topics that address areas of public health importance, that represent timely scientific opportunities, and/or that are currently underfunded areas in need of increased emphasis. When used together with a discretionary funding or select-pay process, the SEAs will help the NICHD meet program needs and take advantage of scientific opportunities, while still ensuring that high quality applications are funded. Complementing the scientific criteria, the NICHD will give special consideration to applications in the SEAs that are submitted by "new investigators" to the field. These include established investigators changing fields and targeting areas that meet NICHD program needs, and/or investigators who have not previously received NIH funding. With the termination of the First Independent Research Support and Transition (FIRST) (R29) Award by the NIH, the criterion allows the NICHD to continue to focus attention on this important group of investigators. PROCESS The process described here represents a change from that which has been in place since 1995 (see the "PURPOSE" section above for complete reference to the previous notice). Under this revised NICHD discretionary funding process, all traditional research grant applications (R01s) that are rated highly by peer review will continue to be paid, ordinarily, in percentile rank order. This ordered funding will continue up to the point where approximately 20 percent of available funds remain. All R01 applications which are being reviewed by the National Advisory Child Health and Human Development (NACHHD) Council in a particular round and that are not paid to that point may then be considered for discretionary funding. With the advice of the NACHHD Council, program staff may recommend funding any of the remaining applications that address the SEAs. The SEAs listed below will be used as the first criteria guiding decisions to pay grants through the discretionary funding or select- pay process. These areas will be used as scientific criteria for the next two years (FY 1999 and 2000). If researchers are deemed to be new investigators, as defined above, this will further support their applications for consideration. NICHD SPECIAL EMPHASIS AREAS FOR DISCRETIONARY FUNDING The following areas are organized in alphabetical order. Alleviation of Reproductive Disorders. Research is sought to investigate: a) potential avenues for the treatment of the sequelae of benign gynecologic or andrologic diseases or disorders, especially those affecting the reproductive tract; b) the mechanisms by which these conditions affect male and female fertility; and/or c) approaches leading to the preservation or restoration of fertility potential by improved diagnosis and management options. Behavioral Studies and Interventions to Prevent Injuries and Diseases of Adults with Origin in Childhood. Emphasis will be placed on identifying behavioral, environmental, social, familial, and educational factors that influence certain life-style and risk-taking behaviors which may lead to childhood injuries, or to diseases among adults that have their origins in childhood. Critical to this topic are studies that address interactions among subject variables, types of risk behaviors, stages of development, sociocultural variables, and environmental and educational programs and interventions that produce resilience, behavioral change and behavioral compliance, over time and across settings. Central Nervous System Development: Normal and Abnormal. Research is encouraged on central nervous system (CNS) development and function, including influences by genetic or exogenous factors, such as infectious agents, trauma, toxic agents and environmental pollutants, that lead to mental retardation or other developmental disorders, such as Down syndrome, phenylketonuria, autism, fetal alcohol syndrome, learning disabilities, neural tube defects, and cognitive and behavioral problems. Studies using animal models (vertebrate and invertebrate) and human subjects, basic studies on processes underlying CNS development, and the application of structural and functional neuroimaging techniques are emphasized. Childhood Antecedents of Adult Disease. There is an increasing amount of epidemiologic evidence which indicates that the pathophysiologic origins of several severe adult diseases may begin early in life. Studies are, therefore, encouraged on fetal and childhood antecedents of chronic diseases which occur later in life, including obesity, insulin resistance, glucose intolerance, Type I and Type II diabetes, dyslipidemia, atherosclerosis, hypertension, and osteoporosis. Studies are also encouraged on developing genetic and biochemical markers to identify infants and children at high risk for these diseases later in life. Contraceptive Development. Basic, applied, and clinical research is sought to develop and test new contraceptive drugs, devices and surgical procedures for either men or women. Studies may involve molecular, cellular, and immunological approaches to regulating gamete production, maturation, and/or fertilization by hormonal or other pharmacological means. Research on physical or chemical barrier methods that can prevent both pregnancy and reduce transmission of sexually transmitted diseases is also encouraged. Environmental Factors and Behavioral Adaptation in Persons with Chronic Disability. Basic or clinical research regarding relationships between environmental factors and the behavioral adaptation to chronically disabling physical conditions is a priority. Areas of interest include: a) basic studies examining intrapersonal (e.g., perceptual-motor, cognitive, emotional, or psychophysiological) changes that occur while people with physical disabilities perform particular tasks in specific environments; b) studies delineating environmental factors (physical, familial, social, or cultural) that influence behavioral adaptation; and c) the development and validation of interventions that utilize any of these factors to promote adaptation. Etiology and Prevention of Low Birth Weight and Prematurity. Birth of infants either too soon (premature) and/or too small (intrauterine growth restriction or IUGR), and the resultant short- and long-term morbidities, continue to be unresolved problems. Research on mechanisms responsible for preterm birth and IUGR and on their prevention and treatment is sought. Interrelationships of Health with Demographic and Social Processes. Demographic studies of health are encouraged, including studies that link demographic processes and infant, child and adult health and well-being; development of relevant, innovative and cost-effective research designs and measurement tools; studies of health over the life course and across generations; and studies of health that take into account the physical and social environment; biologic and genetic factors, socioeconomic and demographic characteristics such as age, education, gender, race and ethnicity, income, wealth; and measures of social and economic inequality, and disability status. Population Movement and Its Interrelationship with Social, Economic, Health, and Environmental Factors. Research is encouraged on the determinants and consequences of population movement, including international migration, internal migration, and residential mobility. Topics of interest include research on the forces that shape these demographic processes; their impact on individual health and well-being, families, communities, and society; processes through which migrants adapt; intergenerational transfers and generational differences; selectivity of migrants; measurement of population movement; modeling of selection effects in studies of contextual effects on demographic behaviors; and research on the interrelationship between the physical environment and population movement. Processes of Normal and Abnormal Development, with Emphasis on Germ Cell Biology and Birth Defects. Development is a continuum, and NICHD's interests cover all facets of pre-, peri-, and postimplantation development (as well as parallel stages in vertebrate and invertebrate models) including gametogenesis and other aspects of germ cell biology, fertilization, embryogenesis and organogenesis. Basic and clinical research is encouraged that seeks to explain the processes underlying both normal and abnormal development, including biological and genetic studies of development and reproduction, as well as the causes and prevention of birth defects. Rational Strategies for the Development of Drugs for Pregnant and Lactating Women, Children, and Persons with Disabilities. The development and testing of new therapeutic agents for infants, children, persons with disabilities, pregnant women, lactating women, and other women of childbearing age has lagged behind new drug development for other populations for a variety of reasons, including safety concerns, dearth of robust outcome measures, reluctance to do studies in these populations and lack of appropriate formulations. Therefore, research to develop rational strategies for drug development and novel therapeutic interventions is needed. Reproductive Endocrinology. Studies are sought that address the biosynthesis and secretion of reproductive hormones; structure-function analysis of reproductive hormone-receptor interactions; evaluation of the signal transduction pathways mediating the mechanism(s) of reproductive hormone action; and the neuroendocrinology-mediating processes that regulate reproduction. Reproductive Epidemiology. Research sought includes: a) epidemiologic studies to determine the efficacy and adverse effects of contraceptive and reproductive drugs, devices and surgical procedures as well as to elucidate the etiology of disorders affecting reproductive health; and b) epidemiologic studies of factors/conditions that affect fertility (in females or males) or cause chronic pelvic pain, including endometriosis and leiomyomata (uterine fibroids), and their treatments. Secondary Complications of Disabling Conditions. Preclinical and clinical studies are encouraged on the pathophysiology and development of conditions that occur secondary to a primary disabling condition. Secondary conditions include, but are not restricted to, pain; spasticity; autonomic dysreflexia; bowel, bladder, or sexual dysfunction; syringomyelia; pressure ulcers and other soft-tissue problems; joint dysfunction; infection; deconditioning; cognitive and memory dysfunction; behavioral dysfunction; and depression. APPLICATION PROCEDURES When submitting an application that appears to be responsive to the SEAs as described above, the investigator should type the title of this notice ("NICHD SEAs for Use in Discretionary Funding") on line 2 of the face page of PHS Form 398, and mark the "YES" box. Applications will be assigned according to the PHS Referral Guidelines and formal determination of the emphasis areas will be made by NICHD staff. INQUIRIES Inquiries regarding this notice are encouraged. The NICHD welcomes the opportunity to clarify any issues or questions from potential applicants. Inquiries regarding the SEAs or the discretionary funding process may be directed to: Sumner Yaffe, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5097 FAX: (301) 402-2085 Email: yaffes@exchange.nih.gov Florence P. Haseltine, M.D. Center for Population Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8B07, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1101 FAX: (301) 496-0962 Email: haseltif@exchange.nih.gov Marcus Fuhrer, Ph.D. National Center for Medical Rehabilitation Research 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: fuhrerm@exchange.nih.gov
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